NCT07221201 Integrating Project YES! With WHO-Endorsed Mental Health Approaches Among Youth Living With HIV
| NCT ID | NCT07221201 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins Bloomberg School of Public Health |
| Condition | HIV - Human Immunodeficiency Virus |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-10-25 |
| Primary Completion | 2026-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2025-10-25 with a primary completion date of 2026-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The proposed study will address the intersecting stigmas of HIV, violence and depression among adolescents and young adults (15-24) living with HIV (AYALHIV) in Zambia. The study will integrate a WHO-endorsed mental health approach into an existing HIV-stigma-reducing intervention, and refine measures of internalized and intersecting stigmas, to create and test the feasibility of Project YES+- a combined youth peer mentoring and lay mental health intervention. This research aims to shift HIV care and treatment for AYALHIV by addressing the multiple internalized and intersecting stigmas that impeded antiretroviral adherence and HIV viral suppression.
Eligibility Criteria
Inclusion Criteria: For youth * Be between ages 15-21 * living within 30-minutes, by personal transportation, of the clinic by self-report, * and being available to attend sessions and data collection over a 4-8 month time period On ART for at least 6 months * On first-line ART * Speaks Bemba For caregivers * Being 25 years of age or older * Caring for an AYALHIV who meets the study eligibility criteria * Speaks Bemba * Living within 30-minutes, by personal transportation, of the clinic by self-report * Being available to attend sessions and data collection over a 4-8 month time period Exclusion Criteria: For youth, * only one youth per household may join. * Also participants will be excluded from joining the RCT if they are at imminent risk of suicide based on WHO guidance on the Self Help plus program.
Contact & Investigator
Julie A Denison, PhD
PRINCIPAL INVESTIGATOR
JHBSPH
Frequently Asked Questions
Who can join the NCT07221201 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying HIV - Human Immunodeficiency Virus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07221201 currently recruiting?
Yes, NCT07221201 is actively recruiting participants. Contact the research team at jdenison@jhu.edu for enrollment information.
Where is the NCT07221201 trial being conducted?
This trial is being conducted at Ndola, Zambia.
Who is sponsoring the NCT07221201 clinical trial?
NCT07221201 is sponsored by Johns Hopkins Bloomberg School of Public Health. The principal investigator is Julie A Denison, PhD at JHBSPH. The trial plans to enroll 400 participants.
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